Kornimate/medical-research-clean huggingface dataset:
imipenem prophylaxis in patients with acute pancreatitis

Conditions: Acute Pancreatitis

Summary: this is a prospective, single-center, randomized, placebo-controlled, double-blind clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with predicted severe acute pancreatitis. all patients with first attack of acute pancreatitis, an onset of disease less than 72h before admission, and an apache ii score ≥ 8 calculated within the first 24h from admission will be enrolled.


Eligibility criteria:
inclusion criteria: * diagnosis of acute pancreatitis defined by the revised 2012 atlanta criteria * first manifestation of acute pancreatitis regardless of etiology * apache ii ≥ 8 calculated within the first 24 hours of admission * onset of symptoms \< 72 hours before admission exclusion criteria: * age \< 18 years * pregnant and breastfeeding women * active and documented infection at admission * concomitant antibiotic treatment or antibiotic treatment present within 72 hours before enrollment * acute pancreatitis diagnosed at surgery * active malignancy * known immune deficiency * patients with chronic pancreatitis * patients unwilling to participate in the trial

Keywords: acute pancreatitis antibiotic prophylaxis imipenem-cilastatin infected pancreatic necrosis infection organ failure
effects of bin therapy on finger gnosia and fine motor skill

Conditions: Down Syndrome

Summary: down syndrome is a hereditary disorder resulting from the occurrence of an additional copy of chromosome 21, resulting in discernible variations in cognitive and physical characteristics. finger gnosis pertains to the capacity to identify and discriminate among individual fingers. tactile perception and body awareness are both encompassed by this particular component. finger gnosis encompasses the sensory and cognitive mechanisms that enable an individual to recognize, label, and differentiate between their own fingers and those belonging to others. the therapeutic approach known as bin therapy is a non-invasive and pharmacologically unassisted intervention that use electrical stimulation as a means to enhance manual dexterity in individuals afflicted with neurological conditions

it will be a randomized controlled trial. 30 patients fulfilling the inclusion and exclusion criteria will be recruited by non-probability convenience sampling and then randomly divided in two groups using lottery method. group a will receive will receive conventional physical therapy exercise program including core strengthening, balance and coordination exercise, fine motor skills activities with 2-3 times a week, with 20-50 minutes of each session with each set comprises of 10-12 repetitions of each exercise. and the group b will receive bin therapy and finger gnosia. sensory assessment will be assess by revised nottingham sensory assessment.

Eligibility criteria:
inclusion criteria: * age range between 5-13 years * children with down syndrome who are able to follow simple instructions. * medically stable participants can participate in therapeutic procedures. * participants and their families should be able to attend bin therapy weekly. exclusion criteria: * any other medical conditions or cognitive impairments that could affect their participation in the study. * history of seizures. * history of heart problems

Keywords: down syndrome bin therapy freely box activties finger gnosia
effect of slow injection of fentanyl on the incidence of spinal anesthesia induced itching in cesarean section

Conditions: Itching

Summary: pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids. sometimes it may be more unpleasant than pain itself. the incidence of pruritus is 83% in postpartum patients and 69% in non-pregnant patients including males and females (1). some researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and effective way to reduce the incidence and severity of hypotension during cesarean section under spinal anesthesia (2). in this new research i want to investigate the effect of slow injection of fentanyl separately, in spinal anesthesia for cesarean section, on the incidence of itching in this double blind randomized study two hundred parturient will be randomly allocated in to two groups; group (r) will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml csf) in 15 seconds. group (s) will receive the same dose in 90 seconds all parturient will receive 10 mg bupivacaine in 45 min after fentanyl. exclusion criteria will be those with allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction. parturient will be monitored regarding the incidence of itching, hypotension, nausea and vomiting. onset and level of sensory block will also be recorded.


Eligibility criteria:
inclusion criteria: * elective and emergency cesarean section parturient. exclusion criteria: * allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.
effect of coffeeberry on mood, motivation and cognitive performance

Conditions: Fatigue, Mental; Alertness; Mood; Motivation; Cognitive Performance

Summary: the primary purpose is to test the short-term effects of the acute consumption of two novel beverages made from coffeeberries, the fruit of the coffee plant (coffea arabica) benchmarked against caffeine on several aspects of cognitive performance. preliminary studies suggest that flavanols and chlorogenic acids can enhance cognitive performance. it is unknown if drinks formulated with flavanols and chlorogenic acids (without high sugar or caffeine) improve cognition or mood to a similar extent as caffeine. coffeeberry beverage comparisons will be made to a flavored positive control beverage containing caffeine and a flavored placebo beverage.


Eligibility criteria:
inclusion criteria: * are older than 17 and under 50 years of age * self-report of good health exclusion criteria: * using any prescription medication including birth control * report hypersensitivity to caffeine * have visual impairment that cannot be corrected with glasses or contact lenses * report any food allergies * self-reported excessive leisure time physical activity (\> 7 strenuous bouts per week) * the presence of current gastrointestinal, sleep, or psychiatric disorder, * report pregnancy/lactation, illegal drug use, smoker * failure to demonstrate adequate minimal performance on lab, computer-based cognitive tasks. * participation in another clinical trial within past 30 days

Keywords: alertness mental fatigue coffeeberry coffee fruit
gastric emptying during labor at term: non-inferiority clinical trial

Conditions: Gastric Emptying; Pregnancy Vomits

Summary: this study evaluates the gastric emptying of pregnant woman at term who received one of the three solutions: maltodextrin, orange juice or coffee with milk.

allocation in maltodextrin, orange juice or coffee with milk will be random using sealed envelopes. gastric ultrasound will be used for estimating gastric volume by measuring antral area in right lateral decubiti. all solutions will have the same volume and total of calories.

Eligibility criteria:
inclusion criteria: * pregnancy at term * fasted with an emptying stomach (assessed by ultrasound) * during labor * no diabetes, esophageal disease, obesity * not emergency * high risk of need of general anesthesia exclusion criteria: * vomiting before the end of the protocol * did not drink the whole solutions * ultrasound not performed for any reason

Keywords: gastric emptying labor maltodextrin orange juice coffee ultrasound
f511 cream in preventing palmar-plantar erythrodysesthesia in patients receiving doxorubicin hydrochloride liposome for metastatic breast cancer

Conditions: Breast Cancer; Palmar-plantar Erythrodysesthesia

Summary: rationale: f511 cream may prevent or reduce palmar-plantar erythrodysesthesia in women receiving doxorubicin hydrochloride liposome for metastatic breast cancer. purpose: this randomized phase iii trial is studying f511 cream to see how well it works compared with a placebo cream in preventing palmar-plantar erythrodysesthesia in patients receiving doxorubicin hydrochloride liposome for metastatic breast cancer.

objectives: * evaluate the effects of f511 cream on the occurrence of palmar-plantar erythrodysesthesia (ppe) in patients with metastatic breast cancer treated with pegylated liposomal doxorubicin hydrochloride. outline: this is a multicenter study. patients receive pegylated liposomal doxorubicin hydrochloride according to local practice on 1, 2, or 4 weeks course schedules with at least 10 mg/m\^2 per week allowed. patients apply f511 cream on one side, hand and foot and the corresponding placebo on the other side hand and foot once daily (the morning) during the first week of the first pegylated liposomal doxorubicin hydrochloride treatment only, then once daily, three times per week thereafter. treatment continues throughout chemotherapy administration in the absence of palmar-plantar erythrodysesthesia (ppe) ≥ grade 2 after completion of study therapy, patients are followed for 30 days. patients with ppe ≥ grade 2 are followed until the ppe resolves to ≤ grade 1.

Eligibility criteria:
disease characteristics: * diagnosis of metastatic breast cancer * no cutaneous metastases on hands or feet * pegylated liposomal doxorubicin hydrochloride monotherapy is indicated according to the local investigator * planned dose at least 10 mg/m\^2 per week * no sign of palmar-plantar erythrodysesthesia (ppe) at study entry patient characteristics: * who performance status 0-2 * able to apply topical medication (cream) or provide for another person to apply cream * not pregnant or breastfeeding * fertile patients must use effective contraception during trial participation and for 1 month after completion * negative pregnancy test * compliant and geographically proximal in order to allow proper evaluation and follow-up * no dermatologic conditions (e.g., psoriasis) that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment * no known allergy or hypersensitivity to f511 cream prior concurrent therapy: * see disease characteristics * more than 30 days since prior and no concurrent treatment with other experimental drugs or anticancer therapy * more than 30 days since prior and no concurrent treatment on another clinical trial * no concurrent local use of other ointments or creams for hands or feet other than excipial repair®

Keywords: palmar-plantar erythrodysesthesia stage iv breast cancer male breast cancer
optimizing body composition & health after breast cancer

Conditions: Breast Neoplasm; Osteoporosis, Postmenopausal

Summary: the purpose of this study is to conduct a 12-month randomized controlled trial comparing the effects of strength training exercise to stretching and relaxation exercise (control) on body composition (bone, muscle and fat mass), energy balance, bone turnover, and physical function (strength, power, gait, balance and self-report physical function and symptoms) in women who experienced premature menopause from chemotherapy for breast cancer.

as a result of treatment, breast cancer survivors typically experience unhealthy changes in body composition (bone, muscle and fat). treatments disrupt normal bone and energy balance resulting in bone and muscle wasting and fat gain. premenopausal women are at greatest risk for these declines because most are thrust into early menopause from chemotherapy. hormone manipulation therapy (i.e., tamoxifen or arimidex) may further affect these tissues. exercise can prevent bone and muscle loss and promote fat loss. however, the ability of exercise to reverse unfavorable changes in all components of body composition in women experiencing early menopause from breast cancer treatment has not been specifically studied.

Eligibility criteria:
inclusion criteria: * diagnosed breast cancer stage i-iiia * completion of a chemotherapy regimen within the previous 5 years * premenopausal status (9-12 menstrual cycles/year) at the initiation of chemotherapy * complete absence of menstrual cycles for at least 6 months and within one year after starting chemotherapy or confirmed menopause by blood tests conducted in the last 12 months prior to enrollment. exclusion criteria: * presence of any known metastases * clinically defined osteoporosis * current or previous use of medications known to affect bone metabolism * current regular participation (\>2x/wk for at least 30 min/session) in planned impact activities (i.e., volleyball, basketball), or resistance training * a medical condition, disorder, or medication that contraindicates participation in moderate intensity impact or resistance exercise

Keywords: randomized clinical trial cancer survivor bone health body composition signs and symptoms
study evaluating single doses of sbi-087 in japanese subjects with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to evaluate the safety and tolerability of single doses of sbi-087 in japanese subjects with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * must meet american college of rheumatology criteria for rheumatoid arthritis with functional class i to iii. * rheumatoid arthritis disease onset at \>16 years of age and duration of disease at least 6 months. * men or women of nonchildbearing potential (woncbp), aged 20 to 70 years, inclusive at the screening visit. exclusion criteria: * any significant health problems other than rheumatoid arthritis. * treatment of greater than 10 mg of prednisone per day. * therapy with immunosuppressants within 6 months before study day 1
gastric volume in elderly patients undergoing staged bilateral total knee arthroplasty

Conditions: Arthritis Knee

Summary: in the past, some guidelines advised no oral intake for at least 8 hours before any surgery, however, research has shown risks associated with excessive fasting, such as postoperative insulin resistance, and advantages in shorter fasting protocols, such as reduced postoperative nausea and vomiting. the perioperative fasting guidelines of the european society of anaesthesiology focus on preoperative carbohydrates. they hold that it is safe for patients to drink carbohydrate-rich fluids up to 2 hours before elective surgery and that drinking carbohydrate-rich fluids improves subjective well-being, reduces thirst and hunger, and reduces postoperative insulin resistance at an evidence level of 1++. nevertheless, data on drinking carbohydrate fluids before surgery in elderly patients are limited. some factors have been known to influence the gastric emptying rate, as for example, old age, pain, and the use of opioid analgesics. in the previous study, evidence of increased pain was reported in patients undergoing staged bilateral total knee arthroplasty, in whom the second operated knee had greater sensitivity (tertiary hyperalgesia) due to the surgical injury to the first operated knee. in the present study, the investigators will evaluate the effect of old age, surgical stress, pain, and the use of analgesics on the residual gastric volume in elderly patients undergoing staged-bilateral total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * patients scheduled for staged bilateral total knee arthroplasty aged 65 to 85 years * american society of anesthesiologists physical status classification 1, 2, and 3 * body mass index \< 35 kg/cm2 * patients administered carbohydrate-containing fluid 2 hours prior to surgery exclusion criteria: * previous surgery of the upper gastrointestinal tract * achalasia * diabetes
effects of konjac glucomannan noodle intervention in subjects with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: metabolic syndrome (ms) is a complex disease with a cluster of risk factors and clinical features, which includes central or abdominal obesity, atherogenic dyslipidemia, impaired glucose regulation, hyperinsulinemia, high blood pressure, and concomitance of pro-inflammatory cytokine and insulin resistance. glucomannan (gm) is a water-soluble dietary fiber derived from the root of amorphophallus konjac that can improve blood sugar, blood fat concentration, and weight management, and has other health benefits.the purposes of this study are going to investigate the effects of kgm noodle (kgn) as stable food to ms and diabetic patients.

the kgn diet was composed of well-cooked noodle with 2 g of kgm in a dosage of 200 g/piece twice daily to substitute the daily carbohydrate for 4 weeks, with a 2-week washout period between alternative diets. all 33 subjects received two servings of either gmns or pns (400 g) per day, which replaced the main carbohydrate in two daily meals for 4 weeks. after a 2-week washout period, the subjects received the other type of noodle for 4 weeks. the body weight, bmi, waist circumference, fasting blood glucose and lipid profile, as well as serum vitamin a, e, β-carotene and high sensitivity c-reactive protein (hs-cpr) were measured by hpcl.

Eligibility criteria:
inclusion criteria: adults with metabolic syndrome subjects were considered to have metabolic syndrome if subjects had 3 of the following 5 characteristics: 1. abdominal obesity (waist circumference \>= 90 cm in men and \>= 80 cm in women) 2. impaired fasting glucose ( \>= 5.6 mmol/l) 3. hypertriglyceridemia ( \>= 1.7 mmol/l) 4. low hdl-c (\< 1.0 mmol/l in men and \< 1.3 mmol/l in women) 5. increased blood pressure (sbp \>= 130 mmhg and dbp \>= 85 mmhg). exclusion criteria: 1. liver and renal diseases 2. undergoing statin therapy 3. pregnancy women 4. taking antioxidant vitamins supplements
liquid biopsies for the personalized management of patients with hereditary diffuse gastric cancer

Conditions: Hereditary Diffuse Gastric Cancer

Summary: activating somatic mutations and methylation profiles identified by liquid biopsies could identify cdh1 and ctnna1 pathogenic variants carriers with invasive diffuse gastric cancer undetectable by upper g-i endoscopy.

carriers of germline pathogenic variants in the cdh1 and ctnna1 genes have the hereditary diffuse gastric cancer syndrome. asymptomatic carriers have at high lifetime risk of diffuse gastric cancer (30-70%). screening upper gastrointestinal endoscopy, even with multiple random biopsies, misses signet ring cell cancer foci. invasive cancers can thus go undetected. there is therefore a recommendation of total risk-reducing gastrectomy, at least in carriers with a family history of gastric cancer. novel screening strategies are needed. in this pilot project, the investigators will perform liquid biopsies of both blood and gastric fluid in asymptomatic carriers who refuse gastrectomy and in controls. the investigators aim to show that somatic mutations in a panel of genes involved in gastric cancer and methylation profiles are detected in a subset of carriers, and not in controls. these could be indicative of invasive cancer undetected by endoscopy, and would thus be a strong argument for risk-reducing gastrectomy. on the contrary, in the absence of somatic mutations in liquid biopsies, endoscopic surveillance could continue.

Eligibility criteria:
inclusion criteria: case: * patient ≥ 18 years old * cdh1 or ctnna1 germline pathogenic variant. * no history of diffuse gastric cancer. * french social security. * ability to understand and willingness to sign a written informed consent document. volunteers: * patients ≥ 18 years old * patients with no oncological history * patients with macroscopically normal oeso-gastroduodenal fibroscopy * french social security. * ability to understand and willingness to sign a written informed consent exclusion criteria: for both arms * patients with cancer being treated * patients with metastatic cancer * medical contraindication to general anesthesia or fogd (bleeding disorder, pregnant women ) * patients under guardianship or curator

Keywords: gastrectomy somatic mutations endoscopy biopsies methylation profil
ultrasound assessment of gastric contents in fasted surgical patients with previous subtotal gastrectomy

Conditions: Gastroparesis

Summary: investigators assess the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy.

investigators evaluate the gastric contents by ultrasonography in fasted patients with previous subtotal gastrectomy, quantitatively and qualitatively. the frequency of visualization fully will be also analyzed.

Eligibility criteria:
inclusion criteria: * the preoperative fasted patients with previous subtotal gastrectomy exclusion criteria: * other anatomical abnormality or mass of stomach except gastrectomy
post marketing trial for evaluating the effectiveness of actigraft in treating lower extremity hard to heal wounds

Conditions: Wounds

Summary: the study is a prospective, single arm, post- marketing study. the subjects enrolled to the study will receive weekly applications of actigraft until complete healing or until investigator's decision that patient can no longer benefit from the study treatment.


Eligibility criteria:
inclusion criteria: 1. subject is ≥18 years of age 2. patient with a chronic lower extremity ulcer (i.e dfu, vlu, ...) 3. ulcer duration \>30 days. 4. ulcer size decreased in less than 30% in the 14 days prior to enrollment, while treated with standard of care (or advanced treatment) 5. subject must be willing to comply with the protocol including having blood drawn to create the actigraft 6. subject can read and understand the informed consent form exclusion criteria: 1. presence of active underlying osteomyelitis. 2. known malignancy in the reference wound bed or margins of the wound 3. cannot withdraw blood in the required amount technically. 4. subject is receiving (i.e., within the past 30 days) systemic steroids (more than 10mg per day) 5. subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (within the past 30 days). 6. subject has been treated with hyperbaric oxygen, wound vac or ozone gas(o3) within the past 5 days or is scheduled to receive during the study

Keywords: chronic ulcer lower extremity dfu vlu
treatment of psoriasis with parathyroid hormone

Conditions: Plaque Psoriasis

Summary: this is a clinical study in two phases. the first phase compares the effect of an ointment containing parathyroid hormone (pth) with the effect of a placebo ointment (inactive ointment without pth) on psoriasis lesions. neither the study participants nor the researchers will know who is receiving pth ointment and who is receiving placebo until the end of this first study phase. the second phase is a study of the pth ointment on large areas of psoriasis to find out how long the effects last.

patients with active plaque psoriasis will be withdrawn from systemic and topical medications. after washout, we will select active psoriatic lesions of at least 25 square cm in size to receive either placebo ointment or a proprietary ointment containing pth for 8 weeks. we will see the patients every 2 weeks. we will evaluate the lesions by examination and digital photography at each visit and measure parameters of calcium metabolism periodically during the 8 weeks. at the conclusion of the 8 weeks, we will obtain punch biopsies from the treated lesions and from one lesion without treatment. if the patients elect, we will transition them into an open label trial with the pth ointment including up to 1000 square cm of psoriatic lesions and monitor them for duration of effect and changes in parameters of calcium metabolism.

Eligibility criteria:
inclusion criteria: * active plaque psoriasis at least 10 percent bsa (body surface area) * age 18-70 exclusion criteria: * abnormalities of calcium metabolism

Keywords: parathyroid hormone psoriasis lesions topical medications ointment calcium metabolism skin biopsy